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FDA 510(k)

C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)

K-Number: K240457 · 2024-07-24

ApplicantPentax of America, Inc.
Decision Date2024-07-24
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) is a medical device manufactured by Pentax of America, Inc.. It received FDA 510(k) clearance on 2024-07-24 under approval number K240457. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)?

C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) is a medical device that received FDA 510(k) clearance on 2024-07-24. It is manufactured by Pentax of America, Inc.. The 510(k) number is K240457.

When was C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) approved by the FDA?

C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) received FDA 510(k) clearance on 2024-07-24, under approval number K240457.

What company makes C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)?

C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) is manufactured by Pentax of America, Inc..

What is the FDA product code for C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)?

The FDA product code for C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) is GEH.

Related Clinical Trials

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Related PubMed Literature

PMID: 36632328 Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation. JAMIA open (2023)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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